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Adverse Event Reporting in Medtronic Infuse Clinical Trials Under Fire

Jun 6, 2012 | Parker Waichman LLP

Serious questions were raised about side effects associated with Medtronic Inc.'s Infuse bone graft product by a study published in The Spine Journal last summer.  The study found that published reports for 13 Medtronic-fund Infuse clinical trials downplayed serious adverse events.  The authors of The Spine Journal report, led by prominent spine surgeon, Dr. Eugene Carragee, also raised questions about the financial relationships some of the researchers who conducted those studies had with Medtronic.

According to a report from MedPage Today, the 13 Medtronic-sponsored studies reviewed by Carragee and his colleagues purportedly found no adverse events attributed to Infuse.  But Food & Drug Administration (FDA) documents and other data sources the team reviewed suggested otherwise, and they found that as many as half of those receiving Infuse could experience serious adverse events, including:

•    implant displacement
•    subsidence
•    infection
•    ectopic bone formation
•    osteolysis
•    leg pain

"In the larger trials, there is evidence in each trial that rhBMP2 complications may be common and may be serious; but in each publication these were unreported," Carragee and his colleagues wrote.

In their editorial, Carragee and colleagues also faulted the way financial ties between researchers and Medtronic were disclosed in the published reports for the thirteen studies. Published payment data indicated that some authors had associations valued at more than $10 million, and disclosures were murky at best.

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